MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-26 for MAICAM 180 PORTABLE CARDIAC CAMERA CAM001 manufactured by Segami & Mai.
[20925673]
Loss/shift of gamma event detection between detector 1 and detector 2 on portable cardiac camera caused unacceptable pt examinations - as reported by interpreting physician - and required repeat studies - including repeat injections of radioactive isotopes - for 3 patients in california. Note - this is a common failure for this system and additional reports will be filed after obtaining additional details and dates. Diagnosis or reason for use: non-invasive cardiology examinations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005197 |
| MDR Report Key | 991020 |
| Date Received | 2008-01-26 |
| Date of Report | 2008-01-26 |
| Date of Event | 2008-01-23 |
| Date Added to Maude | 2008-02-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAICAM 180 PORTABLE CARDIAC CAMERA |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2008-01-26 |
| Model Number | MAICAM 180 |
| Catalog Number | CAM001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 960680 |
| Manufacturer | SEGAMI & MAI |
| Manufacturer Address | 8325 GUILFORD RD, STE B 9051 RED BRANCH RD, STE C COLUMBIA MD 21056 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-26 |